Position Title: Senior R&D Engineer – EU MDR Remediation

Location: Connecticut (Hybrid – 3 days onsite, 2 days remote)

Employment Type: W2 Only

Our client, a prominent Medical Device manufacturer based in Connecticut, seeks an experienced Senior R&D Engineer specializing in EU MDR Remediation. This role offers a balanced work arrangement, with three days onsite and two days remote per week.

Responsibilities:

1. Research and Development (R&D) Engineering: Lead initiatives to refine product design specifications, leveraging over 8 years of expertise in the Medical Device field.

2. Remediation Strategy Development: Devise and execute strategies to rectify compliance issues in alignment with EU MDR standards, employing a nuanced understanding of remediation methodologies.

3. Effective Communication and Documentation: Demonstrate exceptional communication skills, both verbal and written, to convey technical concepts effectively. Produce meticulous design control documents, including Input Output Verification and Validation (IOVV) and Requirements Traceability Matrices (RTMs).

4. Orthopedic Implant Specialization: Utilize extensive experience in orthopedic implant projects to contribute significantly to design and development endeavors. Candidates must have specific experience with joint implants.

5. EU-MDR Compliance Assurance: Ensure compliance with EU Medical Device Regulation requirements by adeptly navigating regulatory frameworks and implementing requisite measures.

Qualifications:

• Bachelor’s degree in Engineering or related field (Advanced degree preferred)
• Over 8 years of progressive experience in R&D engineering within the Medical Device industry
• Profound understanding of remediation methodologies and compliance standards
• Excellent verbal and written communication skills
• Demonstrated expertise in orthopedic implant design and development, specifically joint implants
• Familiarity with EU-MDR regulations and compliance procedures

Job Title: Manufacturing Process Engineer

Location: San Francisco Bay Area

Duration: 9+ months

Industry: Medical Device

Job Description:

We are seeking a skilled and experienced Manufacturing Process Engineer to join our team in the San Francisco Bay Area. In this role, you will be responsible for optimizing and improving manufacturing processes, specifically focusing on plastic injection molding processes within the medical device industry. The ideal candidate will have a strong background in engineering principles, along with hands-on experience in plastic injection molding.

Key Responsibilities:

1. Develop and implement manufacturing processes for plastic injection molding in compliance with industry standards and regulations.
2. Optimize existing manufacturing processes to improve efficiency, quality, and cost-effectiveness.
3. Conduct root cause analysis and troubleshoot manufacturing issues to ensure smooth production operations.
4. Collaborate with cross-functional teams including R&D, Quality Assurance, and Production to drive continuous improvement initiatives.
5. Provide technical expertise and support for process validation activities, including IQ/OQ/PQ.
6. Ensure compliance with regulatory requirements such as FDA regulations and ISO standards.
7. Stay updated on industry trends and advancements in plastic injection molding technology to identify opportunities for process enhancements.
8. Train manufacturing personnel on new processes and technologies to ensure proper implementation and adherence to best practices.

Requirements:

• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or related field.
• Minimum of 3 years of experience in manufacturing engineering, with a focus on plastic injection molding processes.
• Experience with RJG or systematic molding certification preferred.
• Strong understanding of engineering principles and manufacturing processes.
• Proficiency in CAD software (e.g., SolidWorks) and MS Office Suite.
• Excellent problem-solving skills and ability to perform root cause analysis.
• Effective communication and interpersonal skills, with the ability to collaborate across teams.
• Knowledge of regulatory requirements such as FDA regulations and ISO standards is a plus

Role: Database Application Engineer

Duration:12 + months

Location: Alpharetta, GA – Local candidates only

Working Model: Hybrid- In Office Tuesday and Thursday every week – Local candidates only

Email: harsha@worklanceinc.com

Responsibilities:
• 10+ years of experience in data engineering.
• Design, develop, and implement scalable data pipelines and ETL/ELT processes using SSIS, Python and API integrations
• Identify existing data capability and infrastructure gaps or opportunities within and across initiatives and provide subject matter expertise in support of remediation
• Collaborate with technical team and business stakeholders to understand data requirements and translate them into technical solutions
• Work with large datasets, ensuring data quality, accuracy, and performance
• Implement data transformation, integration, and validation processes to support analytics and reporting needs
• Optimize and fine-tune data pipelines for improved speed, reliability, and efficiency
• Implement best practices for data storage, retrieval, and archival to ensure data accessibility and security
• Troubleshoot and resolve data-related issues, collaborating with the team to identify root causes
• Document data processes, data lineage, and technical specifications for future reference
• Review and analyze existing data collection systems, and make recommendations on improvement, maintenance, or other factors to improve the system.
• Develop, build, and implement new data collection systems where needed.
• Provide training and guidance on new systems that are being implemented.
• Participate in code reviews, ensuring adherence to coding standards and best practices
• Collaborate with other teams to automate deployment and monitoring of data pipelines
• Proven experience in data engineering, with a strong track record of designing and implementing data solutions
• Proficiency in programming languages such as Python, Java, or Scala, and experience with data processing frameworks (Spark, Hadoop, etc.)
• In-depth understanding of data warehousing concepts, cloud platforms (GCP), and data modeling techniques
• Strong knowledge of SQL and NoSQL databases, as well as data integration and transformation tools(SSIS)
• Passion for and engagement with emerging trends in data, AI/ML, analytics, and digital experiences
• Experience in data product development, analytical models, and model governance
• Experience in anonymizing data and managing the use of data
• Experience in data hygiene procedures, identity resolution capabilities or data management a plus
• Familiarity with BI technologies (e.g. Microsoft Power BI, Tableau)
• Ability to create strategies and plans that define how information can be utilized to support an organization’s overall business strategy, and how that information and data is organized, and governed inside an organization
• Familiarity with industry best practices for collection and use of data
• Outstanding problem-solving skills and the ability to navigate complex data challenges
• Proven abilities to take initiative and be innovative
• Analytical mind with a problem-solving aptitude
• Effective communication and collaboration skills to work with both technical and non-technical stakeholders

MUST HAVE SKILLS:
Microsoft SQL Server
Microsoft Business Intelligence(SSIS,SSAS & SSRS)
Python
GCP Data Services
Tableau

EDUCATION/CERTIFICATIONS:
• Bachelor’s or Master’s degree in Computer Science, Engineering, or a related field
• Microsoft/Oracle SQL, GCP Data Engineer Certification, Tableau Data Analyst Certification

send your resume to harsha@worklanceinc.com

Job Title: Python Developer

Location: Irving, TX

Duration: 12 months

Company: WorkLance Inc.

Email: harsha@worklanceinc.com

Job Description:

WorkLance Inc. is seeking a seasoned Python Developer proficient in PostgreSQL database management, spatial data handling, and multiprocessing solutions. This pivotal role involves crafting, refining, and streamlining spatial data processing pipelines and applications.

Responsibilities:

• Design, develop, and sustain Python-based applications and tools tailored for spatial data analysis and visualization.
• Execute and fine-tune PostgreSQL database schemas, queries, and performance enhancements for effective spatial data management.
• Pioneer multiprocessing solutions to elevate data processing efficacy and scalability.
• Engage in cross-functional collaboration to grasp requirements and furnish robust, scalable solutions.
• Keep abreast of industry trends and emerging technologies in spatial data analysis, Python development, and database management.

MUST HAVE SKILLS (Most Important):

• Bachelor’s degree in Computer Science, Engineering, or a related field.
• Demonstrated expertise (8 years) in Python development, particularly in data processing and spatial data analysis.
• Proficiency in PostgreSQL database management, encompassing schema design, query optimization, and performance tuning.
• Hands-on experience with spatial data formats (e.g., GeoJSON, Shapefiles) and libraries (e.g., GeoPandas, Shapely).
• Familiarity with multiprocessing techniques and libraries (e.g., multiprocessing, concurrent.futures) for parallel processing.
• Outstanding problem-solving aptitude and adeptness in thriving within a fast-paced, collaborative setting.
• Strong communication skills, capable of elucidating technical concepts to non-technical stakeholders.

DESIRED SKILLS:

• Master’s degree in Computer Science, Engineering, or a related field.
• Proficiency with GIS (Geographic Information Systems) tools and libraries (e.g., GDAL, PostGIS).
• Familiarity with cloud computing platforms (e.g., AWS, Azure, Google Cloud) and associated services (e.g., S3, EC2, Google BigQuery).
• Knowledge of containerization technologies (e.g., Docker, Kubernetes) for deployment and scalability.
• Contributions to open-source projects pertaining to Python development or spatial data analysis.

To apply, please send your resume to harsha@worklanceinc.com. We look forward to hearing from you!

Title: ETL Developer

Location :Irving, TX

Duration:12 months

We are seeking a skilled Data Developer to join our team. The ideal candidate will have expertise in designing, implementing, and maintaining ETL/ELT processes to facilitate data integration, migration, and transformation. This role requires proficiency in both cloud and local solutions, as well as a strong understanding of database management systems, data warehousing concepts, Python scripting, dbt (data build tool), and spatial data sources.

Responsibilities:
1. Design, develop, and maintain ETL/ELT processes to extract data from various sources, transform it according to business requirements, and load it into target databases/data warehouses.
2. Collaborate with stakeholders to understand data integration needs and translate them into ETL requirements.
3. Implement solutions using both cloud-based platforms (such as AWS, Azure, or Google Cloud) and local solutions (such as Apache NiFi, Talend, Informatica, or custom scripts).
4. Optimize workflows for performance, scalability, and reliability, considering factors like data volume, frequency, and complexity.
5. Ensure data quality and integrity throughout the process by implementing data validation and error handling mechanisms.
6. Monitor jobs, troubleshoot issues, and perform debugging and performance tuning as needed.
7. Document processes, data mappings, and system configurations to maintain comprehensive documentation.
8. Stay updated on industry trends and best practices.

MUST HAVE SKILLS (Most Important):
1. Bachelor’s degree in Computer Science, Information Technology, or related field.
2. Proven experience as an ETL Developer or similar role, with a strong understanding of data concepts and methodologies.
3. Proficiency in SQL and experience working with relational databases (e.g., MySQL, PostgreSQL, SQL Server, Oracle).
4. Hands-on experience with tools and frameworks, both cloud-based (e.g., AWS Glue, Azure Data Factory, Google Cloud Dataflow) and local (e.g., Apache NiFi, Talend, Informatica).
5. Proficiency in Python programming language for scripting, automation, and data manipulation tasks..
6. Familiarity with spatial data sources and geospatial analysis tools (e.g., PostGIS, GeoPandas, ArcGIS) for handling location-based data.
7. Strong understanding of GIS (Geographic Information Systems) concepts and spatial data formats (e.g., shapefiles, GeoJSON).
8. Familiarity with data warehousing concepts, dimensional modeling, and data integration patterns.
9. Knowledge of cloud computing platforms and services, including storage, compute, and networking.
10. Strong analytical and problem-solving skills, with the ability to troubleshoot complex data pipeline issues.
11. Excellent communication and collaboration skills, with the ability to work effectively in a team environment and interact with stakeholders at various levels of the organization.


DESIRED SKILLS:
1. Experience with big data technologies (e.g., Hadoop, Spark, Clickhouse), NoSQL databases (e.g., MongoDB, Cassandra) and traditional RDMS (PostgreSQL)
2. Certification in cloud computing (e.g., AWS Certified Developer, Azure Developer Associate).
3. Experience with version control systems (e.g., Git) and CI/CD pipelines.
4. Knowledge of data governance principles and regulatory requirements (e.g., GDPR, HIPAA).

Send your resume to harsha@worklanceinc.com

Position: Apigee Platform Engineer

Location: Irving, TX or Remote (East or Central Time Zone)

Duration: 12 months

Interview Process: 1 Technical Interview, 1 General Interview

Experience: 5+ years (or below with relevant expertise)

Start Date: May 2024

Responsibilities:

1. Subject Matter Expertise (SME) in APIGEE (OPDK and/or Hybrid): Demonstrate proficiency in APIGEE platform operations, implementation, troubleshooting, monitoring, and management.

2. Incident Analysis and Coordination: Analyze incidents, collaborate with application owners to troubleshoot and resolve issues related to the APIGEE platform.

3. Platform Maintenance: Conduct platform upgrades, base image upgrades, certificate updates, scaling, and other maintenance tasks regularly.

4. Root Cause Analysis: Lead root cause analysis sessions to identify production issues and devise preventive solutions for the future.

5. Capacity Planning and Management: Participate in capacity planning activities to ensure the Apigee platform can accommodate current and future transactions.

6. Adherence to SLAs: Ensure adherence to Service Level Agreements (SLAs) by resolving tickets promptly.

7. System Health Monitoring: Conduct system health checks and report anomalies for proactive maintenance.

8. Apigee Instance Management: Set up and manage Apigee instances/clusters distributed across data centers.

9. On-call Support: Provide on-call support for the Apigee platform to address any emergent issues.

Requirements:

• Solid experience in Apigee platform – APIGEE (OPDK and/or Hybrid).
• Proficiency in managing the platform and providing production support.
• Knowledge of Continuous Integration/Continuous Deployment (CI/CD) practices.
• Experience in coordinating with application owners for issue resolution.
• Ability to lead root cause analysis sessions and propose preventive measures.
• Familiarity with capacity planning and management techniques.
• Strong communication skills and ability to work effectively in a remote or distributed team environment.

PACKAGING DEVELOPMENT ENGINEERS:

Design, develop, and implement components used for the packaging of incoming raw materials, final product, and product shipment. Perform Gap analysis on existing document to align with the latest standards. Review validation documents including process validation plan documents, risk assessment, traceability matrix, and summary reports. Identify root causes for quality issues and compliance concerns and implement corrective actions. Master’s degree in Science, Technology, or Engineering (any) is required. Work location: Schaumburg, IL and various unanticipated locations throughout the U.S.

QUALITY ENGINEERS:

Lead and participate in investigations, develops plans and executes tasks to solve process problems including Non conformances (NC), complaint investigations and audit observations. Design and develop Risk Management plan and DFMEA and PFMEA. Develop and execute commissioning, IQ and PV protocols, changes requests, gap & root cause analysis, summary reports for facilities, equipment & processes. Write engineering change orders related to Corrective and Preventive Actions (CAPAs). Prepare, & submit documentation for quality compliance to regulatory authorities. Master’s degree in Science, Technology, or Engineering (any) with 1 year of experience in job offered or related occupation is required. Work location: Schaumburg, IL and various unanticipated locations throughout the U.S.

Send Resume to HR Dept., Worklance, Inc., 1821 Walden Office Square, Suite 400, Schaumburg, IL 60173.

Should the candidate accept employment with Worklance, Inc., the referring employee will be eligible to receive an award of $1,000.00 for the successful referral.

Fill out the form below 

Location: Bothell, WA

About Us:
The MSAT (Manufacturing Sciences and Technology) team at Juno Manufacturing Plant (Jump) is dedicated to maintaining the highest standards of quality and compliance in biotechnology and cellular therapy manufacturing. We are committed to driving innovation, continuous improvement, and ensuring regulatory adherence in all aspects of our operations.

Role Overview:
The Deviation Investigator is a pivotal role within the MSAT team, responsible for investigating and managing deviations to ensure compliance with regulatory standards. The successful candidate will collaborate cross-functionally, collect pertinent data, conduct thorough investigations, and implement corrective actions to prevent deviations from reoccurring. This role requires expertise in GMP compliance, strong communication skills, proactive problem-solving abilities, and a commitment to quality and continuous improvement.

Key Responsibilities:
Actively manage deviations to achieve Right First Time (RFT) and on-time phase completion, including deviation closure by the original due date.
Partner with investigation teams to define investigation plans, gather necessary data, and ensure alignment on root cause and Corrective and Preventive Actions (CAPA).
Facilitate the investigation/CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements.
Ensure smooth transition of CAPA to the owning department SME and timely implementation to ensure on-time deviation closure.
Lead investigation of department-specific trend deviations, including deep-dive analysis, root cause evaluation, and assessment of previous CAPA effectiveness.

Qualifications:
Minimum Bachelor’s degree in relevant Science or Engineering discipline or equivalent combination of work experience.
5+ years of relevant cGMP experience, preferably in the biotechnology and/or cellular therapy field.
Minimum of 2 years working within quality systems managing deviation and CAPA records.
Experience authoring deviation and CAPA records.
Demonstrated proficiency in GMP compliance and FDA/EMA regulations.
Excellent written and verbal communication skills.
Proven ability to work cross-functionally and develop strong business partner relationships.
Innovative, proactive, and resourceful mindset with a commitment to quality and continuous improvement.
Ability to anticipate and mitigate challenges effectively.

If interested, comment below or send your resume to:
puspanjali.s@worklanceinc.com
harsha@worklanceinc.com

Fill the form below.

Our client is a globally distinguished medical device manufacturer who specializes in the development and commercialization of innovative medical devices to improve patient lives around the world. Our client currently needs a Systems Engineer, specificaly referred to as a BLE Telemetry System Designer to support the development and design of Bluetooth Low Energy (BLE) telemetry systems used in medical devices.

 location:

Minneapolis, MN

Responsibilities: 

• Design and develop Bluetooth Low Energy (BLE) telemetry systems for medical devices, ensuring compliance with industry standards, regulations, and best practices
• Collaborate with hardware and firmware engineers to define system requirements and develop specifications for BLE-based communication protocols
• Conduct feasibility studies and evaluate different hardware and software solutions to identify the most suitable options for BLE integration
• Create detailed system architecture and design documentation, including block diagrams, flowcharts, and interface specifications
• Develop and implement software algorithms and protocols for data transmission, synchronization, and error handling within the BLE telemetry system
• Perform system-level testing and verification, including integration testing and troubleshooting of hardware and software components
• Collaborate with external vendors and suppliers to source and evaluate BLE modules, sensors, and other components required for the telemetry system
• Collaborate with cross-functional teams to ensure seamless integration of the BLE telemetry system into the overall medical device design

Qualifications: 

• BS Degree Minimum, and 4-7 years of Medical Device experience
• Proven experience in designing and developing BLE telemetry systems for medical devices or a related industry
• Proficiency in software development using programming languages such as C, C++, or Python
• Familiarity with wireless communication technologies and protocols (e.g., Wi-Fi, Zigbee, NFC).
• Experience in hardware and firmware integration, including circuit design, PCB layout, and debugging
• Solid understanding of medical device regulations and standards, such as ISO 13485 and FDA guidelines

Preferred Skills: 

• Experience with wireless medical device connectivity and interoperability standards, such as IEEE 11073
• Familiarity with data encryption and security protocols for BLE communication in medical devices
• Knowledge of embedded systems and real-time operating systems (RTOS).
• Experience with software development tools and methodologies, such as Agile or Scrum
• Familiarity with medical device risk management processes, including hazard analysis and mitigations

Position: Senior Quality Engineer

Company: Our prestigious client in the Medical Device industry is currently seeking a qualified individual for the role of Senior Quality Engineer on a contracting basis. This challenging position requires active involvement in a dynamic team of QA Engineers dedicated to managing numerous projects continuously, with a primary focus on the development of new products, Change Management (LCMs), and initiating the new pipeline (MPD) within the R&D Wound Closure domain.

Required Experience:

• Minimum of 4 years of work experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical).
• Significant experience in the medical device industry, preferably with a diverse product background.
• Analytical Proficiency: Strong statistical analysis skills with a thorough understanding of compliance and regulatory requirements. The ideal candidate should excel in crafting comprehensive documentation.
• Quality System Knowledge: Fundamental understanding of Quality Systems Regulations (QSR), including Design Control, and Good Manufacturing Practices (GMP).
  • Medical Device product risk management
  • Medical devices process validation
• Ability to develop and present to leadership.
• Strong collaboration and teaming skills in a diverse team environment are essential.
• Onsite Commitment: The role requires individuals to be onsite for a minimum of 3-4 days a week, in alignment with the ongoing needs of the business.
• Bachelor’s Degree in Engineering, Biology, Science, Chemistry, or related technical field is required.

Preferred Qualifications:

• Advanced Degree
• Prior experience in a Quality/Quality Engineering role.
• Fundamental understanding of pharmaceutical GMPs.
• Experience in statistical analysis and statistical analysis tools such as Minitab is preferred.
• Experience in applying various risk management and risk mitigation tools.
• Experience with Test Method Validations, Root Cause Analysis, CAPA & Non-Conformance Management, and Process Validations.

Application Process:

If you meet the aforementioned qualifications and are eager to contribute to our team or fill out the form below,  We anticipate reviewing your application.

Key Responsibilities:

• Conduct equipment instrument qualification and Installation Qualification (IOQs).
• Safeguard data integrity throughout the validation process.
• Develop and meticulously document validation materials, including system configurations, specifications, user requirements, and risk assessments.
• Leverage your experience in the pharmaceutical industry to ensure compliance with industry-specific practices and regulations.
• Empower Software experience is a definite plus, enhancing the efficiency of the validation process.

Requirements:

• Minimum of a Bachelor’s degree in a relevant field.
• A minimum of 4 years of experience in a similar role.
• Prior experience within the pharmaceutical industry is essential.
• Familiarity with Empower Software is advantageous.

Details:

• Location: Bothell, WA (North Creek facility).

Location: Albany, NY

Duration: 6+ Months

Job Type: Contract

Responsibilities:

1. Cleaning Validation Protocol Development:

   • Develop, review, and execute cleaning validation protocols for equipment, with a focus on manual cleaning processes such as swabbing and rinsing.

2. Risk Assessment and Mitigation:

   • Assess potential risks related to cleaning processes and implement necessary corrective and preventive actions.

3. Execution and Documentation:

   • Perform hands-on validation activities, including swabbing and rinsing procedures, and maintain thorough documentation of all activities.

4. Analytical Testing Oversight:

   • Coordinate and oversee analytical testing of cleaning samples, working closely with the Quality Control team to interpret results.

5. Collaboration and Communication:

   • Collaborate with manufacturing, quality assurance, and regulatory affairs teams to ensure alignment with industry standards and regulatory requirements.

6. Continuous Improvement:

   • Identify opportunities for process improvement and efficiency in cleaning validation procedures, implementing best practices and staying informed about industry trends.

Apply Now – Fill out the form Below 

Job Opportunity: Senior Packaging Engineer

Location: New Jersey (NJ)
Rate: $50-55 per hour
Duration: 12-month contract

Company Overview: Join a global leader in the consumer goods industry, dedicated to delivering innovative products. Seeking a talented Senior Packaging Engineer to lead packaging development.

Key Responsibilities:

• Primary and Secondary Package Development:

  • Lead design and development for new/existing products.
  • Ensure packaging meets requirements, standards, and sustainability goals.

• Research and Development (R&D):

  • Drive innovation in packaging materials, processes, and technologies.
  • Conduct feasibility studies and stay updated on industry trends.

• Project Lead Capacity:

  • Manage projects from concept to commercialization.
  • Develop timelines, milestones, and budgets for timely delivery.

• Cross-Functional Team Leadership:

  • Collaborate with R&D, manufacturing, marketing, and QA teams.
  • Foster a collaborative environment encouraging creativity and problem-solving.

• Commercialization Qualification:

  • Demonstrate a track record of successful packaging commercialization.
  • Conduct testing and validation for packaging performance and compliance.

Qualifications:

• Bachelor’s degree in Packaging Engineering, Biomedical, Mechanical, or related field.
• 5+ years of professional experience in the high-volume consumer electronics industry.

If passionate about packaging innovation and ready to contribute to a dynamic team, apply to the below form. Fill the form below